This policy addresses the granting of licenses in Form 29 under the Drugs and Cosmetics Rules, 1945, for manufacturing drugs for examination, testing, analysis, Clinical Trials (CT), or Bioavailability and Bioequivalence (BABE) studies. It clarifies the interplay between these rules and the New Drugs and Clinical Trials Rules, 2019, which require applicants to obtain permission from the Central Drugs Standard Control Organisation (CDSCO) for new drugs and Investigational New Drugs before applying for a Form 29 license. To streamline the application process and address concerns, CDSCO issued Notice No. 120120DC Pt. 51 on 18.02.2020, providing clarity on application submission and processing. Further, CDSCO Notice No.PG298importTL2019DCGI dated 20.02.2020, mandates that applications under the New Drugs and Clinical Trials Rules, 2019, will be processed within 07 working days. The policy requests all State/UT Drugs Controllers to process applications for Form 29 licenses within 07 working days of receipt. The Standard Control Organization Public Grievance Cell, FDA Bhawan, Kotla Road, New Delhi-110002 is the relevant body.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules in India governing the manufacture, sale, and distribution of drugs and cosmetics. Licenses in Form 29 are granted under these rules.
Form 29: A license issued under the Drugs and Cosmetics Rules, 1945, to manufacture drugs for examination, test or analysis, CT or BABE study.
State Licensing Authorities: Government bodies at the state level in India responsible for granting licenses related to drugs and cosmetics.
New Drugs and Clinical Trials Rules, 2019: A set of rules in India governing the approval and regulation of new drugs and clinical trials.
CDSCO: Central Drugs Standard Control Organization, the national regulatory body in India for pharmaceuticals and medical devices.
CT or BABE study: Clinical Trial or Bioavailability and Bioequivalence study. These studies are conducted to test the efficacy and safety of drugs.
FDA Bhawan, Kotla Road New Delhi: Location of Standard Control Organization Public Grievance Cell in Delhi, India
MoHFW: Ministry of Health and Family Welfare, a governmental body in India.
F. No-PG/298/i;mportTL/201 9-DCGI
ConD ti rr ae ee Genr em rm ae ln ot f o Hf e aIn ld ti ha Services.
“ Standard Control Organization
(Public Grievance Cell)
FDA Bhawan, Kotla Road
New Delthi-110002,
To, Dated Le /2$20
All State/UT Drugs Controller,
Subjjeect: ct:Grant of License in Form 29 under the Drugs and Cosmetics Rules, 1945 - reg.
Sir / Madam,
Under the provision of Drugs and Cosmetics Rules, 1945, State Licensing Authorities
grant licenses in Form 29 to manufacture drugs for purpose of examination, test or analysis,
CT or BA/BE study.
However, a under vtodh:e New Drugs and Clinical Trials Rules, ; 2019 , the appliicant is
required to obtain permission from CDSCO for new drugs and Investigational New Drugs,
before obtaining the license in Form 29 under the Drugs and Cosmetics Rules, 1945.
; Concerns have been raised on certain aspects of submission and processing of such
applications under the New Drugs and Clinical Trials Rules, 2019 and the Drugs and
Cosmetics Rules, 1945.
In this regard, recently, CDSCO has issued a Notice No. 12-01/20-DC (Pt. 51)
18.02.2020 giving clarity on various aspects relating to submission and processing of such
applications for grant of permission to manufacture trial batches of new drug or investigational
new drug for test and analysis, CT or BA/BE study.
Further, to streamline the process, CDSCO has also decided that such applications
under New Drugs and Clinical Trials Rules, 2019, will be processed within 07 working days
and accordingly, a Notice has been issued vide No.PG/298/import/TL/2019-DCGI dated
20.02.2020.
Copies of the above mentioned two Notices are enclosed for ready reference.
In view of above, you are requested to consider that applications for grant of license in
Form 29 under the Drugs and Cosmetics Rules, 1945 are also processed within 07 working
days of receipt of the applications.
Copy for information to:-
JS(R), MoHFW, Nirman Bhavan, New Dethi